Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) Retrospectively (From 1/7/2009) and Prospectively (up to 31/12/2013) as First Line Treatment for Patients With Locally Advanced or Metastatic Colorectal Cancer (With or Without KRAS Mutation). Assessment of Toxicity, Compliance and Survival of Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 670
- 试验地点
- 6
- 主要终点
- Number of Participants with AE
研究概览
简要总结
Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with metastatic Colorectal Cancer.
详细描述
In addition investigators propose to assess the compliance of patients to treatment and the efficacy of treatment. That means percentage of objective responses, duration of response, frequency of curative liver resection after the administration of treatment, progression free survival and estimation of overall survival
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Histologically confirmed metastatic or locally advanced non-operable colorectal cancer
- •No prior first line treatment for metastatic colorectal cancer
- •Age ≥18 years
- •One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
- •ECOG performance status ≤2
- •Adequate haematological, renal and hepatic function
- •Urine protein <2+ (dipstick)
- •Life expectancy of ≥12 weeks
排除标准
- •Previous first line treatment for metastatic colorectal cancer(progression >6 months after the end of adjuvant treatment)
- •Previous radiotherapy to target lesions
- •Patients with brain metastases and/or cancerous meningitis
- •Metastatic infiltration >50% of the liver parenchyma
- •Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
- •Patients participating in interventional clinical trial
结局指标
主要结局
Number of Participants with AE
时间窗: Every 2 weeks up to 12 weeks
In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks.
次要结局
- Number of Participants with Response Rate(Disease evaluation at Week 6)
- Percentage of Patients with Progression Free Survival(1 year)
- Patients Overall Survival(1 year)